A Study of Venetoclax in Participants With Relapsed or Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma in the Presence of 17p Deletion

  • STATUS
    Recruiting
  • End date
    Sep 28, 2026
  • participants needed
    70
  • sponsor
    AbbVie
Updated on 26 November 2020
Investigator
AbbVie_Call Center
Primary Contact
Concord Repatriation & Gen Hos /ID# 201261 (3.5 mi away) Contact
+36 other location
cancer
lymphoid leukemia
chronic lymphocytic leukemia
lymphoma
measurable disease
venetoclax
lymphadenopathy
lymphocytosis
chronic lymphocytic leukemia refractory
17p deletion

Summary

This is a Phase 2, open-label, single-arm, multicenter study, evaluating the efficacy of venetoclax in participants with relapsed or refractory Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL) in the presence of 17p deletion.

Details
Treatment venetoclax
Clinical Study IdentifierNCT02966756
SponsorAbbVie
Last Modified on26 November 2020

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Eligibility

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Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have Chronic Lymphocytic Leukemia?
Do you have any of these conditions: leukemia chronic lymphocytic or chronic lymphocytic leukemia (cll) or b-cell small lymphocytic lymphoma or Chronic Lymphocytic Leukemia or Lymphocytic...?
Do you have any of these conditions: small lymphocytic lymphoma or chronic lymphocytic leukemia (cll) or b-cell small lymphocytic lymphoma or Chronic Lymphocytic Leukemia or leukemia chro...?
Participant must have a diagnosis of relapsed or refractory chronic lymphocytic leukemia (CLL)/SLL that meets 2008 Modified International Workshop for Chronic Lymphocytic Leukemia (iwCLL) NCI-WG Guidelines and the following
Participant must have an indication for treatment according to the 2008 Modified iwCLL National Cancer Institute-Working Group (NCI-WG) Guidelines
CLL participant must have measurable disease (B-lymphocytosis greater than 5 10^9/L or an enlarged lymph node(s) (LDi > 1.5 cm at baseline) or hepatomegaly or splenomegaly due to CLL)
SLL participant must have presence of lymphadenopathy and absence of cytopenias caused by a clonal marrow infiltrate
Participant must have relapsed or refractory CLL/SLL after receiving at least one prior line of therapy
Participant must have 17p deletion, assessed by a central laboratory
Participant must have an Eastern Cooperative Oncology Group (ECOG) performance score of less than or equal to 2
No known active severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection
Participant must have adequate bone marrow function, coagulation profile, renal, and hepatic function, per laboratory reference range at Screening

Exclusion Criteria

Participant has undergone an allogeneic stem cell transplant
Participant has developed Richter's transformation confirmed by biopsy
Participant has prolymphocytic leukemia
Participant has active and uncontrolled autoimmune cytopenias (for 2 weeks prior to screening), including autoimmune hemolytic anemia (AIHA) and idiopathic thrombocytopenic purpura (ITP)
Participant has previously received venetoclax
Participant is known to be positive for Human Immunodeficiency Virus (HIV)
Participant has received a biologic agent for anti-neoplastic intent within 30 days prior to the first dose of study drug
Participant has received any of the following within 14 days or 5 half-lives (whichever is shorter) prior to the first dose of study drug, or has not recovered to less than Common Toxicity Criteria for Adverse Events (CTCAE) grade 2 clinically significant adverse effect(s)/toxicity(s) of the previous therapy
Any anti-cancer therapy including chemotherapy, immunotherapy, radiotherapy or targeted small molecule agents
Investigational therapy, including targeted small molecule agents
Participant has known allergy to both xanthine oxidase inhibitors and rasburicase
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Step 4 Get your study results

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